Novartis to begin trial of hydroxychloroquine treatment for COVID-19

Swiss pharma giant Novartis has reached an agreement with the US Food and Drug Administration (FDA) to launch a trial of evaluating hydroxychloroquine against the novel coronavirus disease, COVID-19.

Hydroxychloroquine, which is derived from chloroquine, was thrust into the global spotlight after US president Donald Trump touted the antimalarial drug’s potential against COVID-19 last month. This followed early data suggesting that chloroquine and hydroxychloroquine may be able to reduce the duration of infection in patients with mild-to-moderate disease.

The FDA then approved the emergency use of both drugs as treatments for COVID-19 in late March, primarily on the back of a small study conducted in France. The results from that trial demonstrated that four out of five of COVID-19 patients treated with chloroquine experienced ‘favourable’ outcomes, with 65 of the 80 patients receiving the treatment improving and being discharged from hospital in an average of less than five days.

Novartis, through its generics division Sandoz, has already donated up to 130 million doses of the treatment for use in a number of investigational clinical trials around the world. That will now include the company’s own study, which will evaluate the use of hydroxychloroquine treatment in 440 patients hospitalised with COVID-19.

The Swiss pharma plans to conduct the trial at more than a dozen sites across the US, and plans to begin enrolment within the next few weeks. Novartis also added that it will make all its intellectual property relating to the use of hydroxychloroquine in COVID-19 available via non-exclusive voluntary licenses or similar methods to ensure broad access to the drug.

The trial will evaluate hydroxychloroquine on its own and also in combination with the antibiotic therapy azithromycin, due to the efficacy demonstrated in the previously mentioned French study of this combination treatment. In that study, when the antimalarial drug was added to azithromycin, a superior response was observed, by a significant margin.

“We recognise the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease,” said John Tsai, Novartis’ head of global drugdevelopment and chief medical officer.

“We mobilised quickly to address this question in a randomised, double-blind, placebo-controlled study,” he added.

Meanwhile, an international group of researchers have suspended a phase 2b trial of higher dose chloroquine as a COVID-19 treatment after increased safety hazards and fatality rates were observed.

Results from the 81-patient study demonstrated that the high-dose chloroquine diphosphate (CQ) arm saw a trend toward higher lethality than the lower dosage.

‘Preliminary findings suggest that the higher CQ dosage (10-day regimen) should not be recommended for COVID-19 treatment because of its potential safety hazards. Such results forced us to prematurely halt patient recruitment to this arm,’ the authors of the study wrote.

‘Given the enormous global push for the use of CQ for COVID-19, results such as the ones found in this trial can provide robust evidence for updated COVID-19 patient management recommendations,’ they added.